More than two years after publishing a draft guidance document in which it proposed to regulate a broad swath of apps as medical devices, on Monday September 23, FDA released a final version of its guidance document, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff.

Although the final guidance retains the basic framework of the draft guidance, it features several significant changes. In particular, the final guidance appears to narrow the scope of mobile apps that FDA intends to regulate as medical devices, and it expands the categories of apps that will be subject to enforcement discretion. At the same time, however, the final guidance leaves open several questions regarding how FDA intends to regulate apps that serve as accessories to other devices, as well as apps that do not clearly fall into the enforcement discretion categories.

The following presentation will provide an overview of the final guidance and highlight take-aways including:

Outlining and understanding the scope of the regulation

What are medical devices?

What apps are regulated by FDA under its device authorities?

What gray areas still exist?

How can industry reduce the risk of FDA regulation?

If an app qualifies as a mobile medical app, what steps should a company take?

Speakers:Chris PruittAssociateCovington & Burling LLP

Scott DanzisPartnerCovington & Burling LLP

Target AudienceMedical Device and Diagnostic Professionals Working in the following areas: